CN104390746B - Welding quality inspection apparatus of transfusion bag and inspection method using the same - Google Patents

Welding quality inspection apparatus of transfusion bag and inspection method using the same Download PDF

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Publication number
CN104390746B
CN104390746B CN201410557367.3A CN201410557367A CN104390746B CN 104390746 B CN104390746 B CN 104390746B CN 201410557367 A CN201410557367 A CN 201410557367A CN 104390746 B CN104390746 B CN 104390746B
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bag
transfusion bag
pressure
water tank
cylinder
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CN104390746A (en
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刘华
高清华
舒文
高林华
牟善平
张瑜
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China Ren Pharmaceutical (rizhao) Co Ltd
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China Ren Pharmaceutical (rizhao) Co Ltd
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Abstract

The invention, which relates to the transfusion bag inspection field of the pharmaceutical industry, provides a novel welding quality inspection apparatus of a transfusion bag and an inspection method using the same. The apparatus comprises a temperature-consistent water tank; and a pressure control unit is arranged at one side of the temperature-consistent water tank. A triangular support is arranged inside the water tank; the top of the support is connected with the inner wall of the water tank by a rotary knob; a base plate is arranged at the bottom of the support; and a cylinder is connected to the support. According to the inspection apparatus based on the structure, a transfusion bag can be placed on the base plate directly; and after the bag is compressed by a piston connected with the cylinder, the whole support is rotated, so that an included angle of 30 to 75 degrees is formed between the bag body and the horizontal direction and thus the air in the bag is centralized to the position near the bag mouth tube or bag bottom; welding positions at the two sides of the bag body can also be inspected and thus leakage can be inspected by observing whether a continuous bubbling phenomenon occurs. Compared with the prior art, the inspection based on the provided method becomes visual, so that the detection rate of the micro leakage phenomenon is substantially improved.

Description

A kind of transfusion bag welding quality check device and the inspection method applying this device
Technical field:
The present invention relates to pharmaceutical industry transfusion bag inspection field, particularly a kind of transfusion bag welding quality check device and should Inspection method with this device.
Background technology:
Big transfusion has supplementary patient body fluid, keeps patient body fluid balance, is the best carrier of medicine simultaneously, so It is most, the most frequently used medicine of Clinical practice.With the development of acceptable packaging material, transfusion bag has progressively replaced traditional glass The transfusion of glass infusion bottle enters clinically, and product quality directly affects the safety of patient in hospital.Plastic flexible package product safety, ring Guarantor, high mechanical strength, surface are transparent smooth, can effectively intercept aqueous vapor infiltration, without harmful plasticizer, filler, Lubricant etc. is it may be said that plastic flexible package transfusion is the huge innovation of transfusion technique and technology.But transfusion bag is deposited during fabrication In bag, not exclusively and periphery welds uneven problem with joint weld, when therefore producing Drug leakage or being affected by external force Existing Seepage.Drug leakage phenomenon has water clock and two kinds of micro- leakage, and when there is water clock, operator can estimate and find and pick Remove, when there is micro- leakage, operator can not estimate discovery, and this micro- leakage phenomenon is the micro hole having 5-10um in transfusion bag Gap, under general pressure, medicinal liquid in transfusion bag can not substantially water clock out, operator's range estimation is difficult to find, but this Plant micro-pore, antibacterial etc. can enter in transfusion bag, leads to medicinal liquid microbiological contamination.This potential hidden danger may cause health to patient Harm, or even develop into critical incident, directly threaten the existence of soft bag infusion manufacturing enterprise.Product matter in order to ensure transfusion Amount, it is ensured that the drug safety of patient, carries out welding quality inspection to transfusion bag and is very important, be also necessary.
In existing current techique method, there is soft bag infusion manufacturing enterprise to adopt manual pressure to check welding quality, both took Consume artificial, False Rate is high, the seepage of not prison welding product micropore manually cannot be detected, lead to product to cause because of seepage again Quality problems become stealthy killer.Separately there is transfusion bag using fixing cylinder or roller-way pressure application visual inspection, whether range estimation has The medicinal liquid oozing out, distinguishes transfusion bag welding quality according to this, exist subject matter have micro- leakage phenomenon cannot quickly, directly monitoring, make Become welding quality defects can not solve rapidly, the production to product and use impact;In addition also have in prior art The equipment it being detected using lifting water tank, but this equipment cannot be accurately positioned to packaging, and cannot exclude outer The interference on boundary, relatively low for micro- leakage recall rate;Also there is the device using vacuum leak hunting, but these device generally existings cannot be right The drawbacks of pack comprehensive detection.
Content of the invention
The problems existing for prior art, the invention provides a kind of brand-new transfusion bag welding quality inspection dress Put and apply the inspection method of this device, this device includes thermostatic water tank, thermostatic water tank side is provided with pressure control device, water It is provided with triangular supports, described cantilever tip is connected with tank inner wall by knob, frame bottom is provided with base plate, bottom in case Movable disc is provided with plate, described support is also associated with cylinder;Using the check device of this structure, can be in conjunction with right Transfusion bag is directly placed on by the inspection method answered, and rotates whole after being compressed by the piston that cylinder connects Frame, makes bag and the position that horizontal direction is in 30~75 degree of angles, makes, on mouth pipe or bag bottom welding position liquid level in bag, to make In bag, air focuses near bag mouth pipe or bag bottom, such that it is able to be hunted leak it is also possible to right by having or not continuous air bubbles and emerge The welding position of belt body both sides is checked, more directly perceived than prior art, and the recall rate for micro- leakage situation greatly improves.
The present invention employs the following technical solutions: a kind of transfusion bag welding quality check device, including thermostatic water tank, thermostatted water Case side is provided with pressure control device, is provided with triangular supports in water tank, and described cantilever tip is passed through in knob and water tank Wall connects, and frame bottom is provided with base plate, base plate is provided with movable disc, described support is also associated with cylinder, cylinder Bottom is connected with piston by connecting rod, and piston can be with link rotatable;Described pressure control device comprises air inlet, described Air inlet connects external pressure table, described external pressure table is provided with pressure regulator valve, external pressure table is connected with handss rotary valve by pressure piping, Described handss rotary valve is connected with cylinder by control piper, and described pressure control device also comprises intrinsic pressure table, and described is intrinsic pressure Table is connected with interior indentor point by pressure piping;
In addition, present invention also offers adopting the method that this device checks transfusion bag welding quality, concrete steps As follows:
First pass through knob by bracket adjustment to upright position, transfusion bag is lain in a horizontal plane on base plate, open air inlet Pressurising, adjusting cylinder by handss rotary valve makes piston decline compression transfusion bag, now pierces interior indentor point in transfusion bag;Complete By knob, whole support is rotated after stating work, is in the position at 30~75 degree of angles to transfusion bag and horizontal direction, make mouth pipe or On bag bottom welding position liquid level in bag, so that air focuses near bag mouth pipe or bag bottom in bag, afterwards can be to Water filling in water tank, to the excessively not whole transfusion bag of water, now adjusts the regulating valve on external pressure table, and then it is defeated to control cylinder to award The pressure of liquid bag between 0.15-0.20mpa, now intrinsic pressure meter pressure should between 0.07-0.12mpa when, 5 points of each pressurize Clock, sees at bag mouth sealing of tube or bag bottom weld has or not continuous air bubbles and emerges, you can judged;
If bubble-free emerges explanation, mouth pipe is connect well with film, bag back welding, you can completes mouth pipe and examines with bag bottom welding position Look into;Carry out it is only necessary to rotate connecting rod when side checks, piston driving transfusion bag and movable disc rotate 90 degree, make transfusion bag Vertical with base plate, pressurize 5 minutes, see that a bag side welding position has or not continuous air bubbles and emerges, this side of explanation if bubble-free is emerged Welding is good, continues the bar that is rotatably connected, carries out the inspection of another side welding position with same method, that is, complete whole transfusion bag weldering Socket part position checks.
Said method system random detection after welding, the pressure therefore it being detected and angle need to correspond to, and otherwise can Product is damaged it is impossible to correctly reflect actual because the leak source that occurs of welding, also just cannot Instructing manufacture control, when with During 30 ° of vertical angle angle >, with the change of angle, in bag, liquid weight itself can produce impact to the pressure direction of bag Change, therefore pressure and angle need to correspond to, specific as follows: cylinder award the pressure of transfusion bag 0.15-0.18mpa it Between when, corresponding angle is 30 ° -50 °, and when pressure is between 0.18-0.20mpa, corresponding angle is 50 ° -75 °, so may be used More accurately to judge whether to weld the leakage occurring, this is one of primary object of the present invention, why so selects It is due to, after reaching above-mentioned angular range, if it exceeds pressure limit given herein above, bag being led to be crushed by pressure and let out Dew, thus cannot judge that also resulting in cannot be to production technology due to welding reason or the rupture of external pressure reason Directed.
In addition show, acceleration shelf test criterion is through water temperature test and long-term storage test: 60 DEG C of placement- 70 DEG C of thermostatic water tanks 30 minutes, press No leakage, can determine that room temperature welds no problem after depositing one month;Place 70 DEG C -85 DEG C Thermostatic water tank 30 minutes, press No leakage, can determine that room temperature welds no problem after depositing three months;Place 85 DEG C of -100 DEG C of constant temperature Water tank 30 minutes, press No leakage, can determine that room temperature welds no problem after depositing six months, and this is due to the temperature pair during welding Welding quality has large effect, and the acceleration shelf test that hot environment can be simulated to welding position, above-mentioned Corresponding relation is the present inventor by depositing to room temperature and high temperature accelerates to deposit after simulation test is compared for a long time to obtain The data obtaining, so as to accuracy rate is up to 95%, therefore can greatly improve the efficiency of detection.
Described thermostatic water tank bottom is provided with discharge outlet, checks and easily can discharge water after terminating, also dependent on The water yield in the random regulating tank of requirement checking;It is provided with angular marking in that context it may be convenient to adjust whole on described knob The anglec of rotation of support.
In sum, using check device and the method for this structure, directly transfusion bag can be placed on, lead to Cross cylinder connection piston compressed after rotate whole support, the position making bag and horizontal direction be in 30~60 degree of angles, make On mouth pipe or bag bottom welding position liquid level in bag, air in bag is made to focus near bag mouth pipe or bag bottom, such that it is able to Hunted leak it is also possible to check to the welding position of belt body both sides by having or not continuous air bubbles and emerging, than prior art More directly perceived, the recall rate for micro- leakage situation greatly improves.
Brief description
Fig. 1 be check device of the present invention structural representation;
In figure 1 is thermostatic water tank, and 2 is transfusion bag, and 3 is support, and 4 is knob, and 5 is cylinder, and 6 is pressure piping, and 7 is interior Pressure table, 8 is pressure regulator valve, and 9 is air inlet, and 10 is external pressure table, and 11 is pressure piping, and 12 is handss rotary valve, and 13 is piston, and 14 is bottom Plate, 15 is interior indentor point, and 16 is discharge outlet, and 17 is movable disc.
Specific embodiment
A kind of transfusion bag welding quality check device, including thermostatic water tank 1, thermostatic water tank 1 side is provided with Stress control Device, is provided with triangular supports 3 in thermostatic water tank 1, described support 3 top is connected with tank inner wall by knob 4, support 3 Bottom is provided with base plate 14, and base plate 14 is provided with movable disc 17, and described support 3 is also associated with cylinder 5, cylinder 5 bottom Portion is connected with piston 13 by connecting rod, and piston 13 can be with link rotatable;Described pressure control device comprises air inlet 9, institute The air inlet 9 stated connects external pressure table 10, and described external pressure table 10 is provided with pressure regulator valve 8, and external pressure table 10 passes through pressure piping 11 It is connected with handss rotary valve 12, described handss rotary valve 12 is connected with cylinder 5 by control piper, and described pressure control device also comprises Intrinsic pressure table 7, described intrinsic pressure table 7 is connected with interior indentor point 15 by pressure piping 6;
Described thermostatic water tank 1 bottom is provided with discharge outlet 16;
The method applying this device to check transfusion bag welding quality, specifically comprises the following steps that
First pass through knob by bracket adjustment to upright position, transfusion bag is lain in a horizontal plane on base plate, open air inlet Pressurising, adjusting cylinder by handss rotary valve makes piston decline compression transfusion bag, now pierces interior indentor point in transfusion bag;Complete By knob, whole support is rotated after stating work, is in the position at 30~75 degree of angles to transfusion bag and horizontal direction, make mouth pipe or On bag bottom welding position liquid level in bag, so that air focuses near bag mouth pipe or bag bottom in bag, afterwards can be to Water filling in water tank, to the excessively not whole transfusion bag of water, now adjusts the regulating valve on external pressure table, and then it is defeated to control cylinder to award The pressure of liquid bag between 0.15-0.20mpa, now intrinsic pressure meter pressure should between 0.07-0.12mpa when, 5 points of each pressurize Clock, sees at bag mouth sealing of tube or bag bottom weld has or not continuous air bubbles and emerges, you can judged;
Wherein cylinder award the pressure of transfusion bag between 0.15-0.18mpa when, corresponding angle is 30 ° -50 °, pressure When between 0.18-0.20mpa, corresponding angle is 50 ° -75 °;
Acceleration shelf test criterion is: places 60 DEG C of -70 DEG C of thermostatic water tanks 30 minutes, press No leakage, can determine that Room temperature welds no problem after depositing one month;Place 70 DEG C of -85 DEG C of thermostatic water tanks 30 minutes, press No leakage, can determine that room temperature No problem is welded after depositing three months;Place 85 DEG C of -100 DEG C of thermostatic water tanks 30 minutes, press No leakage, can determine that room temperature is deposited No problem is welded after six months.

Claims (3)

1. a kind of transfusion bag welding quality check device, including thermostatic water tank (1) it is characterised in that: thermostatic water tank (1) side sets It is equipped with pressure control device, in thermostatic water tank (1), is provided with triangular supports (3), knob (4) is passed through on described support (3) top It is connected with tank inner wall, support (3) bottom is provided with base plate (14), base plate (14) is provided with movable disc (17), described Cylinder (5) is also associated with support (3), cylinder (5) bottom is connected with piston (13) by connecting rod;Described pressure control device Comprise air inlet (9), described air inlet (9) connects external pressure table (10), described external pressure table (10) is provided with pressure regulator valve (8), external pressure table (10) is connected with handss rotary valve (12) by pressure piping (11), and described handss rotary valve (12) passes through control piper It is connected with cylinder (5), described pressure control device also comprises intrinsic pressure table (7), described intrinsic pressure table (7) passes through pressure piping (6) it is connected with interior indentor point (15).
2. transfusion bag welding quality check device according to claim 1 it is characterised in that: described thermostatic water tank (1) Bottom is provided with discharge outlet (16).
3. the method that check device described in application claim 1 checks transfusion bag welding quality, specifically comprises the following steps that
First pass through knob by bracket adjustment to upright position, transfusion bag lain in a horizontal plane on base plate, open air inlet pressurising, Adjusting cylinder by handss rotary valve makes piston decline compression transfusion bag, now pierces interior indentor point in transfusion bag;Complete above-mentioned work By knob, whole support is rotated after work, be in the position at 30~75 degree of angles to transfusion bag and horizontal direction, make mouth pipe or bag bottom On portion welding position liquid level in bag, so that air focuses near bag mouth pipe or bag bottom in bag, afterwards can be to water tank Interior water filling, to the excessively not whole transfusion bag of water, now adjusts the regulating valve on external pressure table, and then controls cylinder to award transfusion bag Pressure between 0.15-0.20mpa, now intrinsic pressure meter pressure should between 0.07-0.12mpa when, each pressurize 5 minutes, see At bag mouth sealing of tube or bag bottom weld has or not continuous air bubbles and emerges, you can judged;
Wherein cylinder award the pressure of transfusion bag between 0.15-0.18mpa when, corresponding angle is 30 ° -50 °, and pressure exists When between 0.18-0.20mpa, corresponding angle is 50 ° -75 °;
Acceleration shelf test criterion is: places 60 DEG C of -70 DEG C of thermostatic water tanks 30 minutes, press No leakage, can determine that room temperature No problem is welded after depositing one month;Place 70 DEG C of -85 DEG C of thermostatic water tanks 30 minutes, press No leakage, can determine that room temperature is deposited No problem is welded after three months;Place 85 DEG C of -100 DEG C of thermostatic water tanks 30 minutes, press No leakage, can determine that room temperature deposits six No problem is welded after month.
CN201410557367.3A 2014-10-20 2014-10-20 Welding quality inspection apparatus of transfusion bag and inspection method using the same Active CN104390746B (en)

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